Kedrion Biopharma and Kamada Ltd. today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immunoglobulin [Human]). The study represents the first and only trial of a currently available Human Rabies Immunoglobulin (HRIG) conducted in children in the U.S. to date. The results have been submitted to the U.S. Food and Drug Administration for review and inclusion as pediatric data in the product’s full prescribing information.
The KEDRAB U.S. Pediatric Trial was conducted at two sites, one in Arkansas and another in Rhode Island. The study included 30 pediatric patients (ages 0-17 years old), each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population. Secondary objectives included the evaluation of antibody levels and the efficacy of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine according to the PEP recommended guidelines.
No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the 84-day study period.
“We know the incidence of kids being exposed to animals that may transmit rabies is high in the U.S. and abroad,” said Novinyo Amega, M.D., Head of U.S. Medical Affairs at Kedrion Biopharma. “However, little data exist that can help clinicians better understand the safety profiles of the various HRIG products currently available. Therefore, we are pleased to see that top-line results of this pediatric study support KEDRAB’s safety profile.”
“This study represents the first clinical trial in the U.S. pediatric population for any HRIG currently available in the US,” said Michal Stein, M.D., Vice President, Medical Director (Immunology) at Kamada. “According to the World Health Organization, 40 percent of people bitten by suspected rabid animals are children under 15 years of age. Despite the large proportion of pediatric cases, limited safety and efficacy data from clinical trials currently exist for this population. Meeting the primary study objective of KEDRAB in children further strengthens our ongoing confidence in the product.”